Microbiological, Analytical, & Packaging Testing, and Sterilization Services for the Medical Device Industry
Infinity Laboratories helps our customers in the Medical Device industry deliver safe and effective products to market. We offer a full suite of laboratory testing services to assist you with regulatory compliance. We are experts in the areas of Sterility Assurance Testing, Facility and Process Validations, Chemical Characterization, Materials Characterization, Packaging and Distribution Validations, and Ethylene Oxide (EO) Sterilization Services.
Patient Safety is our top priority, and our laboratory testing and sterilization services play a critical role in the delivery of safe and sterile medical devices to our customers. We are there to help you confirm the efficacy and safety of your products. We complete rigorous validations to ensure that every medical device that we test meets the strict regulatory requirements that your products require by complying with ISO, AAMI, ASTM, and other applicable standards.
Sterility Assurance Testing
Our network of laboratories provides the critical sterility assurance testing services that are required by medical device, pharmaceutical and biotech companies to support both sterile and nonsterile products.
Bioburden tests are used to determine the total number of viable microorganisms that are on or in a medical device, component, package, or container. This testing is required by many standards and acts as an early warning system for problems in controlled areas that could lead to issues with inadequate sterilization.
Product Sterility and Biological Indicator Sterility (BI) testing is a critical piece of any sterility assurance program. We offer testing in traditional cleanrooms and isolator sterility tests must be validated by performing a method suitability test (Bacteriostasis/Fungistasis or B/F).
LAL testing is an in vitro assay used for the detection and quantification of bacterial endotoxins (USP <85>). This test is performed as lot release requirement for medical devices with direct or indirect contact with the cardiovascular or lymphatic systems or with cerebrospinal fluid. Routine monitoring of incoming raw materials and water systems for bacterial endotoxins will ensure that your processes aren’t contributing endotoxins to your finished device or product.
Extractables and Leachables Testing
Understanding the complex chemical interactions in medical device materials is critical to designing a proper Extractables and Leachables (E&L) program. Our team has years of experience working with a variety of medical device materials and pharmaceutical products.
We specialize in in chemical characterization of medical device materials for regulatory filings. Our extractables and leachables (E&L) program is constructed around ISO 10993-12 (sample preparation) and ISO 10993-18 (chemical characterization). We routinely carry out exhaustive extractions, simulated-use extractions, accelerated aging studies, and leachable studies—all per ISO 10993 guidance. Extraction solutions are typically evaluated, depending on solvent utilized, by LC-MS, GC-MS, and ICP-MS. The end report of an extractable study will list detected compounds and their in-sample concentrations.
Packaging & Distribution Validation Testing
Our Packaging Testing Services include Validation Testing (ISO 11607), distribution simulation (ASTM D4169), material qualifications, package design and consulting services. Our highly qualified laboratory staff brings decades of experience and expertise to each validation test requested. We help confirm packaging performance and integrity, helping you troubleshoot any packaging-related issues and conduct in-depth failure analysis. Common tests include Atmospheric Conditioning (ASTM D4332), Accelerated Aging (ASTM F1980), Tensile Strength (ASTM F88), Gross Leak (ASTM F2096), Burst Testing (ASTM F1140, Dye Penetration (ASTM F1929), and Visual Inspection (ASTM 1886)
Cleanroom Certification and Testing Services
A Cleanroom is a specially constructed room in which the air supply, air distribution, filtration of air supply, materials of construction, and operating procedures are regulated to control airborne particle concentrations to meet appropriate cleanliness levels and other relevant parameters (e.g. temperature, humidity, pressure, etc.).
Infinity Laboratories provides onsite Cleanroom Certifications, Environmental Monitoring (EM), and Cleanroom validation services to ensure that your cleanrooms and facilities are compliant with the regulations as defined by ISO 14698.
EO Sterilization Services
Ethylene Oxide (also known as EO or EtO) is a process widely used to sterilize a variety of healthcare products, such as single-use medical devices and pharmaceutical containers. EO sterilization can efficiently penetrate the surfaces of most medical devices and its lower temperature makes it an ideal process for a wide variety of materials. Per ISO 11135 and CFR 820 requirements we can validate your product in our 3M™ Steri-Vac™ sterilizers in preparation for routine sterilization at our facility.
Infinity Laboratories is a powerful network of state-of-the-art testing facilities that are FDA Registered, ISO 17025 Accredited and DEA licensed. We continuously work to enhance and protect patient lives through the critical testing services that we provide. Our goal is to go Beyond Testing and become a partner in the success of our customers.